Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Cefalexin monohydrate
Ceva Santé Animale
QJ01DB01
Cefalexin monohydrate
300 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
cefalexin
Antibacterial
Authorised
2010-04-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Therios 300 mg palatable tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet. Round scored beige palatable tablet. The tablet can be divided into halves and quarters. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial skin infections in dogs (including deep and superficial pyoderma) caused by organisms sensitive to cefalexin. For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by organisms sensitive to cefalexin. 4.3 CONTRAINDICATIONS Do not use in animals which are known to be hypersensitive to penicillins, cephalosporins or any of the excipients Do not use in case of severe renal failure Do not use in rabbits, guinea pigs, hamsters and gerbils. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. ACTIVE SUBSTANCE: Each tablet contains: Cefalexin (as cefalexin monohydrate).............. 300 mg For a full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _1_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _4_ _2_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Whenever possible, the use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Read the complete document